Lactate Gen.2 3183700190

GUDID 04015630918911

Roche Diagnostics GmbH

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Primary Device ID04015630918911
NIH Device Record Key1033d2f4-7127-4c4f-8df1-b4fc31fe9311
Commercial Distribution StatusIn Commercial Distribution
Brand NameLactate Gen.2
Version Model Number3183700190
Catalog Number3183700190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630918911 [Primary]

FDA Product Code

KHPACID, LACTIC, ENZYMATIC METHOD

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

On-Brand Devices [Lactate Gen.2]

0761333612135108057940190
040156309269545401666190
040156309251485171881190
040156309189113183700190

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